A Dose-ranging Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler (DPI) and an HFA MDI

Summary

This study is examining how well a dry powder inhaler albuterol medication (DPI) works to
help adult and adolescent subjects 12 years of age and older with persistent asthma improve
lung function. During the trial the participant will also be given an HFA
(hydrofluoroalkane), metered dose inhaler. albuterol. These medications will be given to
the participant at two different doses. Approximately Sixty-six (66) participants will be
enrolled in the study following screening and a 14 day run-in period. Participants who
qualify for the study will be selected randomly to receive all of the treatments, on
separate occasions, 3-7 days apart There will be 5 visits where the medications are given.
The total number of clinic visit is approximately 7 visits to the clinic.

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Medical and Biotech [MESH] Definitions

Albuterol

A racemic mixture with a 1:1 ratio of the r-isomer, levalbuterol, and s-albuterol. It is a short-acting beta2-adrenergic agonist with its main clinical use in ASTHMA.

Albuterol, Ipratropium Drug Combination

A combined pharmaceutical preparation of Ipratropium Bromide and Albuterol Sulfate that is used to treat the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

Levalbuterol

The R-isomer of albuterol.

Therapeutic Misconception

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Placebo Effect

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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